News

Protalex Issues Letter to Shareholders

FLORHAM PARK, N.J.--(BUSINESS WIRE)--
Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company,
announces that Arnold P. Kling, President, and Chief Executive Officer
of Protalex, has issued a Letter to Shareholders providing a business
update. The full text of the Letter, which has also been posted to the
company's website, follows below.

To My Fellow Shareholders:

Protalex started 2017 with several advances to our global clinical
development programs of our lead product, PRTX-100,
a highly-purified form of Staphylococcal protein A (SpA), as a
potentially safe and effective new treatment for autoimmune diseases,
that position us for continued advancement throughout the balance of
the year and beyond.

We continue to enroll our Phase 1/2 dose escalating studies of PRTX-100
as a potential new treatment for chronic immune thrombocytopenia (ITP)
in the U.S. (the 202 Study) and in Europe (the 203 Study). To meet the
challenge of patient recruitment associated with an orphan disease like
ITP, we markedly expanded the number of clinical sites in both the U.S.
and Europe. Last week we began patient screening in the United Kingdom
to augment the 203 Study in Europe. With this expansion, we now have more
than 20 sites worldwide open for patient enrollment.

The 203 study is an ascending dose phase 1/2 focused on adult with ITP
who have failed one prior treatment. The 202 study includes adults with
chronic ITP who have proven refractory to thrombopoietin agonists. We
expect to complete the second cohorts of each of these studies shortly
and look forward to advancing both studies to their third cohorts. For
additional information on trial design and study sites, please visit www.clinicaltrials.gov.

We are encouraged by our initial results in both the 202 and 203
Studies, which thus far show an acceptable safety profile to support
continued enrollment into higher-dose cohorts in both trials. We have
observed two platelet responses, as defined per protocol, in the trials,
as described in part in an abstract published for the American Society
of Hematology conference in December 2016.

Regulators have granted PRTX-100 Orphan Drug Designation as a
potential treatment for ITP in both the U.S. and Europe. This status
provides commercial exclusivity benefits, tax credits for certain
research, potential research grants and a waiver of the New Drug
Application user fee in the U.S. Earlier this year, we applied for a
$500,000 grant for our ITP trials with the Office of Orphan Products
Development (OPD) in the U.S. Food and Drug Administration (FDA). We are
pleased to report that our application received a Priority Score of 20,
which is a competitive ranking as scores are graded 0-90 with zero being
the highest score. We believe that we will likely receive the grant
because scores better than 30 received funding in previous grant cycles.
We will receive notification by the end of September and, if awarded,
will receive the funds shortly thereafter.

We recently initiated a study of PRTX-100 in an animal model of
Myasthenia Gravis (MG) and expect to have top-line results from that
study sometime in the 3rd quarter of 2017. MG is an
autoimmune disorder caused by anti-self antibodies that react with the
neuromuscular junction causing muscle weakness and fatigability. MG
remains underdiagnosed in the United States and has an estimated
incidence of 14 to 20 per 100,000 population, thus approximately 36,000
to 60,000 cases in the U.S.1 Current treatments, which
include corticosteroids and immunosuppressant agents, are not optimal as
they can cause severe adverse events. As neurological autoimmune
disorders in general lack efficacious treatments without adverse side
effects, we believe that achieving positive results in the mouse
preclinical model of MG could widely expand the development and
application of PRTX-100 in other neurological autoimmune conditions.

We continue to invest in expanding our global intellectual property
portfolio as part of our commitment to broadly protect our
proprietary immunomodulatory SpA technology. We continue to fortify our
patent estate to support our comprehensive strategy for the development
and commercialization of PRTX-100 in a variety of autoimmune and
inflammatory diseases. In the past year, we were granted seven key
international patents that protect and expand the uses for PRTX-100 in
autoimmune diseases, including rheumatoid arthritis (RA), ITP, and MG,
among others.

We are especially grateful to the patients, clinicians,
collaborators, and employees who have contributed to our progress
and who will continue to help us succeed. We believe that the next 12
months will be a period of both confirmation of the safety and efficacy
of PRTX-100 as a potential treatment for ITP, as well as one of
expansion of its potential indications and uses.

On behalf of our Board of Directors and management team, I thank you
for your continued interest in and support of Protalex as we advance
our plans to bring potential new treatment options to patients suffering
with autoimmune diseases such as RA, ITP and MG.

Sincerely,

Arnold P. KlingPresident

About PRTX-100

PRTX-100, a new generation immunomodulatory therapy, is a
highly-purified form of SpA, an immunomodulatory protein known to modify
aspects of the human immune system. PRTX-100 has the ability, at very
low concentrations, to bind to human B-lymphocytes and macrophages and
to modulate immune processes. Pre-clinical data indicate that PRTX-100
may have the potential to treat ITP by reducing the immune-mediated
destruction of platelets. The two most recently approved drugs used to
treat ITP, Nplate® (romiplostin) and Promacta®/Revolade™ (eltrombopag)
increase the production of platelets but do not appear to affect the
underlying platelet destruction process.

The safety, tolerability, and pharmacokinetics of PRTX-100 have been
characterized in six clinical studies. In three Phase 1b clinical trials
in adult patients with active RA, PRTX-100 was generally safe and well
tolerated at all dose levels, and at certain higher doses, more patients
showed improvement in measures of RA disease activity than did patients
at the lower dose or placebo cohorts. PRTX-100 is administered as a
short intravenous infusion.

Nplate® is a registered trademark of Amgen, Inc. and Promacta®/Revolade™
are registered trademarks of Novartis A G.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on
the development of a class of drugs for treating autoimmune and
inflammatory diseases including RA and ITP. In the U.S., Protalex has
open INDs for the treatment of RA and ITP, and in Europe, an open IMPD
for ITP. Please visit Protalex’s website at www.protalex.com
to learn more about Protalex and its lead drug candidate, PRTX-100.

Forward-Looking Statements

Statements in this press release that are not statements of historical
or current fact constitute "forward-looking statements." Such
forward-looking statements involve known and unknown risks,
uncertainties and other unknown factors that could cause the Company's
actual operating or clinical results to be materially different from any
historical results or from any future results expressed or implied by
such forward-looking statements. In addition to statements that
explicitly describe these risks and uncertainties, readers are urged to
consider statements that contain terms such as "believes," "belief,"
"expects," "expect," "intends," "intend," "anticipate," "anticipates,"
"plans," "plan," to be uncertain and forward-looking. The
forward-looking statements contained herein are also subject generally
to other risks and uncertainties that are described from time to time in
the Company's filings with Securities and Exchange Commission.